NCT02409212

Brief Summary

Study design: The study is a two arm randomised controlled trial (randomisation ratio 1:1) comparing an aerobic exercise training intervention to usual care plus exercise advice. The primary outcome is the feasibility of the intervention as novel primary therapy in men with localised prostate cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_2 prostate-cancer

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 6, 2015

Completed
25 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 30, 2019

Status Verified

January 1, 2019

Enrollment Period

3.6 years

First QC Date

January 20, 2015

Last Update Submit

January 29, 2019

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Feasibility as measured by rate of recruitment

    The rate of recruitment will be measured by comparing the number of patients screended to the number of patients recruited. This will allow us to asses if a future full-scale trial is feasible.

    36 months

Secondary Outcomes (1)

  • Feasibility as measured by Intervention adherence

    36 months

Study Arms (2)

Intervention

EXPERIMENTAL

12 months of aerobic exercise training with behaviour change support

Behavioral: Aerobic exercise training

Comparison

PLACEBO COMPARATOR

Optimal active surveillance according to NICE guidelines and written exercise guidelines from Macmillan cancer

Behavioral: Placebo surveillance and written exercise guidelines

Interventions

Aerobic exercise trainingBEHAVIORAL

Aerobic exercise training will be undertaken for 12 months, combining supervised and independent exercise sessions. Behaviour change counselling will take place bi-monthly, either via face to face sessions during exercise or via telephone by study clinical exercise specialist according to participant preference.

Intervention
Placebo surveillance and written exercise guidelinesBEHAVIORAL

Optimal active surveillance according to NICE guidelines and written exercise guidelines from Macmillan cancer

Comparison

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • In accordance with NICE active surveillance guidelines, men:
  • Who have been evaluated using a combination of clinical, bio-chemical, imaging and/or biopsy, within the last 12 months
  • With histologically confirmed low or intermediate risk prostate cancer, Gleason score ≤7 (3+4, not 4+3)
  • With up to T2a clinical stage tumours
  • With pre-treatment PSA ≤20 ng/mL
  • Who are willing to participate in optimal active surveillance and provide written informed consent
  • With life expectancy of ≥10 years

You may not qualify if:

  • Men:
  • With unstable angina
  • With uncontrolled hypertension
  • With recent myocardial infarction (within the past 6 months)
  • With pacemakers
  • Already undertaking regular physical activity (greater than 90 minutes of moderate intensity exercise, per week) will be excluded
  • With any other physical or mental limitation preventing participation in trial assessments
  • Participating in other clinical trials which might bias the evaluation of the primary objectives of the present study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheffield Teaching Hospitals NHS Trust

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Derek Rosario, MD

    University of Sheffield / Sheffield Teaching Hospitals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2015

First Posted

April 6, 2015

Study Start

May 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

January 30, 2019

Record last verified: 2019-01

Locations

GB(1)